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Can Prophylactic Foraminotomy Prevent C5 Palsy?

This study is investigating if a procedure called prophylactic bilateral foraminotomy can prevent a complication known as C5 palsy (C5P) after cervical decompression surgery. C5P is a rare but serious side effect that causes weakness in the arm and shoulder muscles, which can affect your quality of life. Researchers will compare patients who receive a bilateral cervical keyhole foraminotomy during their cervical decompression surgery (which can include laminoplasty, laminectomy, or discectomy and fusion) to those who only receive cervical decompression. The study aims to see if adding the foraminotomy procedure reduces the occurrence of C5P, which will be measured at discharge, two weeks, and three months after surgery. To join, you must be a Cleveland Clinic patient diagnosed with cervical myelopathy without radiculopathy, undergoing posterior cervical decompression involving the C4-C5 interspace between 2016 and 2018.

Study design
This interventional study plans to enroll 480 participants. It compares two surgical approaches for cervical decompression.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for C5 Palsy upon discharge, 2 weeks postoperatively, and 3 months postoperatively.

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NCT03023696

Can Prophylactic Foraminotomy Prevent C5 Palsy

Recruiting
NAAges 18+InterventionalTreatment
The Cleveland Clinic
~480 participants
Updated 2026-01-22 on ClinicalTrials.gov
What's tested:Bilateral Cervical Keyhole ForaminotomyCervical Decompression

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
C5 Palsy
Measured over Upon discharge, 2 weeks postoperatively and 3 months postoperatively

Conditions

Myelopathy, Compressive
Radiculopathy, Cervical
C5 Palsy

Explore related trials

Cervical myelopathy

Where it's being run

1 sites across 1 states
Ohio1

Study leadership

  • Thomas E Mroz, MD · PRINCIPAL_INVESTIGATOR · The Cleveland Clinic

Who to contact

Nya Robinson
[email protected]
2164441741
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Eligibility criteria

Inclusion

Cleveland Clinic patients who have been diagnosed with cervical myelopathy, without radiculopathy, and will undergo posterior cervical decompression involving the C4-C5 interspace between 2016 and 2018. This includes patients undergoing cervical laminoplasty and cervical laminectomy and fusion.

Exclusion

Any patient younger than 18 years of age will not be included on the basis of skeletal immaturity. Patients with C5 radiculopathy - defined in our study as the existence of preoperative deltoid muscle weakness in grade 3 or less by MMT - will be excluded. Any patients who have undergone previous cervical spine surgery, or who have any spinal malignancy, trauma or infection will be excluded in order to eliminate the confounding effect of multiple surgical interventions.

What this trial measures

  • C5 PalsyUpon discharge, 2 weeks postoperatively and 3 months postoperatively

    Using manual muscle testing and upper extremity sensory exam findings to determine C5 palsy status. C5P is defined as: a reduction of at least 1 in deltoid and/or biceps brachii manual muscle testing scores compared to preoperative scores, without any deterioration of myelopathic symptoms.